333 Regulatory Submissions Jobs - Page 6

As a Statistical Programmer, your role will involve providing statistical input to the design, analysis, reporting, and interpretation of clinical studies, as well as contributing to publications. You will utilize SAS or other software to develop custom programming code for generating tables, data listings, graphs, and derived datasets as specified in the protocol or statistical analysis plan. Ensuring that all outputs meet quality standards and project requirements is crucial in this role. Key Responsibilities: - Perform validation programming and collaborate with other Programmers, Biostatisticians, and project team members to resolve any discrepancies or findings. - Keep the project team ...

As a selected intern at Noccarc Robotics, you will have the opportunity to contribute significantly to the development and validation of critical care devices, particularly ICU ventilators and patient monitors. Your role will involve the following responsibilities: - Conducting clinical validation tests for ICU ventilators, patient monitors, and other critical care devices in hospital and laboratory settings. Collaborating closely with intensivists, respiratory therapists, and ICU staff to evaluate product performance. - Designing and implementing ex-vivo and in-clinic testing protocols to ensure the functionality, accuracy, and safety of devices. - Collecting, analyzing, and interpreting cl...

As a Statistical Programmer in our clinical research team, you will have the crucial responsibility of programming, validating, and delivering statistical outputs for clinical trials. Your role will involve ensuring compliance with regulatory standards and industry best practices. Key Responsibilities: - Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting - Map clinical trial data to CDISC standards (SDTM and ADaM) to ensure regulatory compliance - Create and maintain analysis datasets following CDISC implementation guidelines - Perform data validation and quality control checks to uphold data integrity - Generate and maintain CDISC documentation inc...

The role involves preparing and reviewing regulatory documents, ensuring compliance with national and international guidelines, and supporting product registration processes. Required Candidate profile Looking for a Regulatory Affairs Officer with 2-3 years of experience in the Pharma/API sector. Candidates should have strong MS Office skills and good communication abilities.

Manage Off-site and Concurrent audits in line with internal and regulatory provisions. Ensure timely and high-quality deliverables to the Audit Committee of Executives and the Audit Committee of the Board. Lead and manage a team of approximately 40 members, ensuring effective utilization of manpower. Plan, design, and implement Off-site and Concurrent audits across business and support functions. Review departmental policies and SOPs, ensuring continuous alignment with best practices. Track and monitor open issues from audits, ensuring timely resolution. Devise audit checklists to strengthen audit effectiveness and coverage. Provide recommendations and suggestions to line management for impr...

Oversees multiple regulatory specialists at clinical research sites, ensuring timely regulatory submissions, IRB documentation, compliance with evolving regulations, training oversight, audit coordination, and accurate maintenance of study records, while demonstrating advanced communication, leadership, multitasking, and regulatory knowledge.

Role Overview: As a Regulatory Medical Writer-Clinical trials (RMW-CT), you will be responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) designated by leadership. Your role will involve supporting the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests. You will be the lead contact for sponsor or designated HA interactions with cross-functional teams, ensuring the accuracy and quality of submission-ready documents. Key Responsibilities: - Serve as the regulatory lead representative on project teams, partnering with outsourcing and operational tea...

As a Senior Medical Writer at ICON, you will be responsible for leading the development and execution of medical writing strategies for clinical trial projects, contributing to the advancement of innovative treatments and therapies. Your key responsibilities will include: - Leading the preparation, review, and editing of various clinical study documents such as clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), patient narratives, and regulatory submissions (CTD modules) to ensure accuracy, clarity, and compliance with regulatory guidelines and industry standards. - Collaborating closely with cross-functional teams, including biostatistics and programming,...

Senior Medical Writer ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical trial projects, contributing to the advancement of innovative treatments and therapies. What you will be doing Leading the preparation, review, and editing of clinical study documents...

Role Overview: As the Statistical Science Director at the organization, you will play a crucial leadership role in advancing the application of statistical science within the pharmaceutical industry. Your extensive experience in statistical methodology, project design, delivery, and interpretation will be instrumental in guiding various stages of product development. Your responsibilities will include leading statistical strategy for projects, contributing to regulatory submissions, and influencing internal governance decisions. The ideal candidate for this role is recognized externally as an expert in statistical methods and possesses the ability to guide complex analyses while mentoring ju...

Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a result of the talents, dedication and commitment of our people to drive our business forward. We provide career advancement opportunities through Gentell University, leadership development programs and executive mentoring. You would be joining a company committed to make it better every day, for our customers and for our employees. The Regulatory Affairs...

We are hiring for a leading Bank - Based at Mumbai Location. Position: IT Audit Manager - CISA (Must) Experience: 5 to 12 Years Mode: WFO (5 Days) Job Role Responsible to deliver multiple IT Audit assignments including IT Application and Infrastructure Audits, Application Security Assessments, Vendor Audits, Concurrent Audits, Thematic Assignments, Regulatory submissions etc. Develop the Risk Based Audit Framework, meeting RBI regulations and adopting ISO 27001 Standards. Manage and liaison with outsourced audit partners with an emphasis on audit time and cost reduction, improvement in efficiency without the need of additional resources and delivery of high-quality audit work products which ...

Summary Of Responsibilities Respond to medical information queries (In French)/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned tracking several types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple so...

Summary Of Responsibilities Respond to medical information queries (In French)/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned tracking several types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple so...

As a Regulatory Affairs Executive, you will play a critical role in managing regulatory documentation and ensuring compliance with ISO guidelines within the manufacturing sector. Your attention to detail and strong knowledge of regulatory affairs will be essential for success in this role. Key Responsibilities: - Manage and maintain all regulatory documentation related to manufacturing operations. - Ensure compliance with applicable ISO guidelines, certifications, and standards. - Coordinate and participate in ISO audits (internal and external). - Prepare, review, and maintain SOPs and documentation for regulatory compliance. - Liaise with different departments to ensure quality and complian...

Role Overview: You are being offered the opportunity to join as an Associate Director, PKPD / Pharmacometrics / NONMEM / SAS Programmer in the Clinical Pharmacology and Quantitative Pharmacology Data Programming team. Your main responsibility will be to prepare, program, validate, and diagnose data to support Pharmacometrics and Clinical Pharmacology analyses. Your influence will be vital in shaping crucial decision-making processes throughout all stages of drug development and regulatory interactions. Key Responsibilities: - Expertly clean, manipulate, transform, and integrate data at both the study and compound level to ensure accurate analysis. - Utilize advanced data integration techniqu...

Job Title: Regulatory In-charge (Semi-Regulated Markets) Company: GenAide Pharmaceutical Pvt Ltd Location: 909, Satyamev Eminence, Science City Road, Near Shukan Mall, Sola, Ahmedabad, Gujarat 380060 About GenAide Pharmaceutical Pvt Ltd: GenAide Pharmaceutical Pvt Ltd is a young, energetic, and rapidly growing pharmaceutical company committed to delivering high-quality healthcare products. We foster a dynamic work environment with a strong emphasis on teamwork and innovation. Join our already developed team and contribute to our exciting journey! Experience: 5 - 6 years in Regulatory Affairs, with a strong focus on semi-regulated markets. Job Summary: GenAide Pharmaceutical Pvt Ltd is seekin...

As an individual responsible for assisting with Clinical Safety and/or PSS operations associated with products, your role will involve managing and processing expeditable adverse events, ensuring timely submission to clients and regulatory agencies if required. Your primary goal is to provide high-quality service to clients in a safe and cost-effective manner. It is essential for you to comply with legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in the Company's Health and Safety Manual. Key Responsibilities: - Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) by maintaining ...

Role & responsibilities Lead formulation strategy for new product development and lifecycle management. Drive end-to-end launch readiness: exhibit batches, scale-up, tech transfer, and validation. Collaborate with cross-functional teams (RA, QA, BD, SCM, PMO) to ensure launch timelines are met. Manage documentation for regulatory submissions (ANDA, CTD, etc.). Oversee equipment readiness, raw material planning, and pilot batch execution. Participate in project review meetings and provide technical updates to leadership. Identify risks and implement mitigation strategies during formulation and launch phases. Mentor and guide junior scientists and technical staff. Preferred candidate profile M...

Role Overview: You will be responsible for managing day-to-day KYC team operations, providing guidance and support to ensure compliance with regulatory requirements. You will conduct periodic reviews and updates of KYC policies and procedures, maintain the compliance framework, and ensure the delivery of regular compliance audits and regulatory submissions. Additionally, you will collaborate with cross-functional teams, establish best practices and SOPs for KYC processes, and act as a liaison between external organizations and internal stakeholders. Key Responsibilities: - Manage day-to-day KYC team operations - Conduct periodic reviews and updates of KYC policies and procedures - Maintain a...

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma. Job Summary Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets. Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures. Preparation of submission...

Job Description Job Title: Regulatory Affairs Excellence Specialistu00A0 Job Responsibilities Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives. Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability. Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease s...

Job Location - Chennai & Hyderabad Keywords Safety Systems, Regulatory submissions, labeling, publishing, RIMS (Veeva, etc.) Roles and Responsibilities Must Have Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Sciences, or Computer Science. 4–8 years of experience in IT testing/validation, with 2–4 years in Regulatory Affairs systems Work with Regulatory Affairs, Publishing, Labeling, and IT teams to understand business processes and URS (User Requirement Specifications). Hands-on experience with Regulatory applications (e.g., Veeva Vault RIM, Lorenz docuBridge, Liquent InSight, Extedo eCTDmanager, or similar). Develop UAT strategy, test plans, test cases, and traceabili...

Role Overview: As a Lead Statistical Programmer, you will be responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role will involve leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy...

Role Overview: ApoPharma, a member of the Apotex group of companies, focuses on discovering and developing new medicines to improve the quality of life for patients with debilitating and life-threatening diseases. The company's major research focus is on investigating the pathological role of iron in human disease and utilizing novel medicines to treat conditions affected by iron. Key Responsibilities: - Prepare quality post-launch Product Life-Cycle Management (PLCM) packages for different markets to ensure timely approval. - Maintain and complete regulatory documents promptly to ensure compliance in various markets. - Coordinate and compile deficiency responses in a timely manner, working ...